We’re officially in year two of the COVID-19 pandemic, and despite early warnings that vaccines could take years to develop, there are now three approved by the U.S. Food and Drug Administration (FDA) for emergency use in adults. The CDC reports that 133 million doses have already been administered.
So when will it be approved for kids? Older teens are already eligible in some areas. The Pfizer vaccine has been authorized for use in people ages 16 and older, and the Moderna vaccine is approved to vaccinate those ages 18 and up. Administration of the single-dose Johnson and Johnson vaccine was paused by the FDA and CDC on April 13 to review side effects concerning blood clots.
Doses for younger children could be approved by late summer, or perhaps sooner. Following their phase three clinical trial of 2,260 participants ages 12 to 15, Pfizer reported 100% efficacy in this teenage age group when administered the same two-shot vaccine approved for adults. The drugmaker has now filed to expand the FDA’s emergency use authorization of their COVID-19 vaccine to include children ages 12 to 15.
Pfizer also recently announced that they will enroll 4,500 children as young as 6 months old into their latest vaccine trial for kids, per ABC News. The trial will be done in three phases, the first to determine the ideal dosage for children in this age group, and the following two to study the vaccine’s efficacy and safety.
Moderna has recently initiated a children’s vaccine trial study through the National Institute of Allergy and Infectious Diseases that includes kids ages 6 months to 12 years old, NPR reported. The trial will include 6,750 children in the U.S. and Canada to measure the impact and efficacy of the vaccine’s two-dose shots, as well as monitor the effects of the vaccine on this age group.
The high efficacy rates shown in trial phases for adults by the currently available vaccines and the beginning of vaccine trials for children mark a promising turn in the fight against COVID-19. However, the speed at which these vaccines have been developed and tested means that there is still much that researchers and physicians alike do not know about the long-term impacts of a vaccine. Questions also still remain about vaccine manufacturing and distribution.
To help address some of the concerns parents may have about COVID-19 vaccines and kids, Romper asked experts to weigh in on some of the biggest questions we have about the vaccine and kids.
At what age is it safe to get a COVID-19 vaccine?
It is unclear at this point what the official recommendation will be for the age of administration of a COVID-19 vaccine, but experts point to other childhood vaccines to make an educated guess. "Some vaccines, like hepatitis B, are safe enough to get close to birth while others, like the influenza vaccine, are given to babies when they are over 6 months old," Los Angeles-based physician Dr. Bita Nasseri tells Romper. She says that since the COVID vaccine is so new, and as far as statistics are concerned, children are affected by the coronavirus differently than adults, it may be advised for kids to wait until they're a bit older to receive the vaccine. But again, there's not yet any official recommendation on this.
What are the potential immediate side effects of a COVID-19 vaccine for kids?
"All vaccines have potential side effects, but we have only just begun trials with children, so we don’t know yet," Dr. Susan V. Lipton, MD, MPH, Chief of Pediatric Infectious Diseases at Sinai Hospital of Baltimore tells Romper. "The object of any vaccine is to limit side effects while preventing the virus or disease."
Based on the current trial research available, Dr. Nasseri explains, "Just like any vaccine, it is expected to cause minor symptoms of a viral infection, including low-grade fever, fatigue, body aches, and muscle soreness." Not because you're being injected with any kind of virus, but because there is a shot site where muscle soreness can occur, and because there is also some research that suggests your immune system is reacting to the vaccine and may have some of these side effects.
More information should be available as the vaccine trials continue and FDA approval is sought. "Most vaccines that have been FDA-approved do not have very commonly occurring serious or life threatening side effects at anything more that one per 100,000 or one per million doses," Nasseri tells Romper.
Are there any known long-term effects of a COVID-19 vaccine?
"Since the vaccines are very new, it is possible that there are either rare reactions or also undiscovered long-term effects," Nasseri tells Romper. "Without proper long-term studies, it's hard to say what those may be and how often they occur."
With the vaccine (and even the virus itself) still in its infancy, it may be some time before any answers to this question are available. "It’s such a new virus that the vaccine has not been studied long term in anyone," Lipton says. "No one can know for sure right now."
Will a vaccine effectively protect children from contracting COVID-19?
"This is a hard answer as most vaccine trials need to demonstrate at least a 50% effect in preventing illness, or alternatively demonstrate at least a 50% decrease in transmission by people who contract the virus. It will also depend on what the rest of the research and each of the clinical trials demonstrate," Nasseri tells Romper.
Despite the promising news of high efficacy rates for both the Pfizer and Moderna vaccine trials, neither company has released study results that directly address either vaccine's efficacy in children specifically.
Nasseri says that there really isn't extensive research on how COVID affects children, except for the rare MIS-C, which occurs in less than one in 10,000 to one in 100,000 children and appears weeks after a COVID-19 infection. "It is therefore difficult to demonstrate that children will have adequate and lasting immunity from any of the vaccines yet," she explains. "Once the trials are completed and a good number of children have received the vaccine and been followed closely for any of the potential side effects, the medical and scientific community can weigh in properly."
As vaccine trials for children begin, data found that the Pfizer-BioNTech COVID-19 vaccine demonstrated 100% efficacy in a phase 3 clinical trial involving 2,260 adolescents aged 12 to 15 years old. Not a single child in the vaccinated group became infected with the virus, and the vaccine apparently produced “robust antibody responses” in the children.
Can kids continue getting their routine vaccinations whether or not they receive the COVID-19 vaccine?
"Kids should absolutely get their routine vaccinations whether or not they receive the COVID-19 vaccine," Lipton tells Romper.
Since current vaccine trials have mostly been administered to adults, these subjects have likely had their adult and childhood vaccinations. "There is limited to no data currently on the interactions with other vaccinations, and the COVID-19 vaccine will come with its own safety protocols," Dr. Niket Sonpal, a New York-based internist and gastroenterologist, tells Romper.
Instrumental in protecting children from illness, it's imperative to continue vaccinations as recommended by your child's pediatrician. Nasseri calls the resurgence of infections such as measles and whooping cough "a realistic concern," to stress the importance of continuing with routine vaccinations.
Can my teenager get the COVID-19 vaccine?
Both your teenager’s age, as well as the type of vaccine, will determine whether they are eligible to get vaccinated in the near future. “The Pfizer vaccine was tested in people 16 years and older and received authorization for use in this age group. The Moderna vaccine received authorization for use in ages 18 years and older,” Zachary Hoy, MD, a pediatric infectious disease specialist at Pediatrix affiliate, Nashville Pediatric Infectious Disease, tells Romper in an email. Your kid would be asked the usual screening questions about potential allergic reactions to the vaccine as well as previous COVID-19 exposure. Remember that all vaccine info is changing, and researchers are working to make the shot available for all teenagers as soon as possible. “Pfizer and Moderna have trials at clinicaltrials.org that are ongoing to enroll children ages 12 years and up to see how they respond to vaccination. As data comes in, the CDC will likely re-evaluate age ranges for the vaccination, but currently these are in clinical trials and not recommended at this time for those below 16 years of age (Pfizer) or 18 years of age (Moderna),” says Dr. Hoy.
But as of now, the exact timeline for a vaccine rollout for teens is still being determined. “Some at the CDC indicate that teenagers may fit into the vaccine timeline in the second half of the year,” says Dr. Hoy.
With that in mind, there are some cases in which teens may be able to receive the vaccine sooner. “A possible exception is if a teenager were an essential worker, such as a volunteer at a hospital, bagging groceries or a grocery store clerk, there may be an ability to get vaccinated at an earlier time,” says Dr. Hoy. “Many vaccination centers have set up online forms to determine risk and schedule vaccination accordingly,” so teenagers who are essential workers for a specific business or organization would likely complete an online form to get their spot in line. In addition, teens with health conditions that may be worsened by a COVID-19 infection could also be eligible to get the vaccine sooner, Dr. Hoy explains.
How long will the vaccine protect children for?
Although there is no data available to answer this particular question, it is worth discussing with your child's physician prior to vaccine administration. "The most important question will be how long does this vaccine confer immunity, and if it will require a repeat booster or yearly injection for new strains," Sonpal explains.
How can parents approach their pediatricians with questions about a COVID-19 vaccine?
During your child's next visit with their doctor, it's likely the topic of vaccines will come up. When it comes to a COVID-19 vaccine, Nasseri says, "Just like any vaccine, it is important to ask their physician if they know the data about the specific vaccine being offered."
Because the information about this specific vaccine is continuously evolving, inquiring about potential side effects and efficacy rate at the time of your visit is a good idea. Your doctor may have access to new information that you have not yet seen.
"I think the best question to always ask when you are concerned about anything recommended by your doctor is, 'Are you doing this for your own children or grandchildren?'" Lipton tells Romper. Your child's pediatrician is the best direct resource you have for specific questions about a COVID-19 vaccine and your kids.
When will we know if the vaccine is safe for kids?
As healthcare workers begin getting the first doses of the Pfizer coronavirus vaccine, the rest of the public has begun to wonder when they may be eligible for vaccination. Parents are still waiting on more information about whether the vaccine is safe for their children, too.
Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital, tells Romper in an interview that we will likely have answers by March 2021.
“The vaccine is approved for 16- and 17-year-olds, but the studies have just started for children 12 and over,” he says. “I think it will be very similar to how they did it with adults, where after the second shot we could see that data in as little as three months. It all depends on what they find and what the FDA board says, but it could be approved for children 12 and over as early as March.” For children under that age, the vaccine trials have just begun.
Where will children fall in line to receive the vaccine compared to the rest of the population?
“As soon as it’s approved, and if everyone already eligible for the vaccine has gotten it by March or April, kids would be very shortly after that,” Rathore says. “The current speculation is that it will be available for everyone in April. It would probably start with kids who are higher risk, but it all depends on how our current implementation is going. There are so many factors and unknowns right now, but I would hope by March or April, children will begin getting the vaccine.”
James Schneider, M.D., board-certified pediatric critical care specialist at Northwell Health, tells Romper in an interview that kids will probably fall behind other, higher-need populations. “If, and when, an approved vaccine becomes available for children, I'd think we, as a country, would still try to vaccinate the most vulnerable in the population — frontline health care workers, the elderly, those with chronic comorbidities at risk for severe COVID-19 — prior to vaccinating children. However, there are children with comorbidities as well that may deserve earlier vaccination. We also know that children, who may often be asymptomatic carriers, may spread the infection to other vulnerable people, making vaccinating children an important part of the public health strategy for overcoming this pandemic.”
Where can parents take their children to get vaccinated?
Parents may be wondering whether the COVID vaccine will be available by request at their pediatrician’s office, like the flu shot, or if they’ll need to go to a special site for their shot, like a local hospital or health department. Rathore says how the vaccines will be distributed to the public depends on a lot of logistical factors, especially the vaccine’s special storage requirements.
“I think it makes the most sense to have it at the pediatrician’s office of course, but it requires a -73-degree freezer to store it in, so I don’t think many pediatricians will have that. The freezer will be the big thing,” he says.
So, while there’s no concrete answer about where kids will be able to get vaccinated, Rathore adds that how vaccines are distributed between now and March will help the vaccine manufacturers develop the best plan.
Will my child need more than one dose of the vaccine to be protected?
The currently-approved vaccines from Pfizer and Moderna requires two doses to fully protect an adult from COVID, per the CDC. Will this be the same for children? And will they need to get their doses once, or annually, like a flu shot?
Schneider says only time will tell.
“With the currently approved Pfizer and Moderna vaccines, we still don't yet know how long immunity will last. And there are other vaccines currently still in the clinical trial phase that we have yet to determine the safety, efficacy, and therefore the duration of the immunity. That information will likely determine whether or not an annual shot will be required. It is quite possible that we will need an annual COVID shot as we currently get an annual flu shot.”
How can I sign my child up for a vaccine trial?
Currently, both Pfizer and Moderna have active vaccine trials for kids. While each manufacturer’s requirements for trial participation varies, the process typically involves receiving the vaccine through a research facility or participating practitioner and then following up for up to a year afterward to study impacts related to efficacy and safety.
Moderna’s vaccine trial for children, which they call KidCove, has a dedicated website that allows parents to check whether or not their child is eligible for the trial through an online survey. The site details the 14-month study, which includes two injections given 28 days apart, and follow-ups via monthly telehealth appointments and six in-person visits.
Information on Pfizer’s website directs parents to search a directory of available vaccine trials (for COVID-19 and other vaccine trials in progress) to learn about what enrollment entails, view eligibility requirements, and find a designated study facility.
Experts:
Dr. Susan V. Lipton, MPH, Chief, Pediatric Infectious Diseases at Samuelson Children’s Hospital at Sinai Hospital of Baltimore and Chief, Section on Infectious Diseases, Maryland American Academy of Pediatrics
Dr. Bita Nasseri, Los Angeles-based physician
Dr. Niket Sonpal, New York-based internist, gastroenterologist, and adjunct professor at Touro College
Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital
James Schneider, M.D., board-certified pediatric critical care specialist at Northwell Health
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